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Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis


N/A
18 Years
N/A
Open (Enrolling)
Both
Cystic Fibrosis

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Trial Information

Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis


The goal of this clinical study is to advance the acceptance of new biomarkers designed to
detect drug-induced kidney injury in clinical trials.

The Kidney Safety Project is being conducted at four major medical centers:

- University of Southern California

- University of Minnesota

- MD Anderson Cancer Center

- Dana-Farber Cancer Institute.

Blood and urine samples will be collected from patients undergoing treatment with either
cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the
proximal tubule of the kidney. Aminoglycosides are a common antibiotic drug taken by
patients with cystic fibrosis. Cisplatin is a common chemotherapy drug taken by patients
with head and neck cancer.

The Aminoglycoside Study of the Kidney Safety Project is being conducted at the University
of Southern California and the University of Minnesota and aims to evaluate aminoglycoside
induced acute kidney injury in patients with cystic fibrosis.

The companion study, the Cisplatin Study of the Kidney Safety Project, is being conducted at
the MD Anderson Cancer Center and the Dana-Farber Cancer Institute and aims to evaluate
cisplatin induced acute kidney injury in patients with head and neck cancer.

The data from the Kidney Safety Project, from both the Aminoglycoside Study and the
Cisplatin Study, will be combined for determination of the best biomarkers for predicting
drug-induced acute kidney injury.

Inclusion Criteria


Inclusion criteria:

1. Males and females ≥ 18 years of age.

2. Documentation of CF diagnosis as evidenced by one or more clinical features
consistent with the CF phenotype and one or more of the following criteria:

- Sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine
iontophoresis test.

- Two well-characterized mutations in the cystic fibrosis transmembrane
conductance regulator (CFTR) gene; or

- Abnormal nasal potential difference.

3. Hospitalized and initiated on systemic antibiotic therapy for treatment of an acute
pulmonary exacerbation.

4. Willingness and ability to comply with study procedures and study restrictions.

5. Ability to provide written informed consent.

Exclusion criteria:

1. Chronic kidney disease defined by microalbuminuria (> 30 mcg/mg creatinine) or eGFR <
60 mL/min/1.73m2.

2. Receiving medications known to alter the tubular secretion of creatinine (e.g.
trimethoprim, cimetidine).

3. Hospitalized for treatment of an acute pulmonary exacerbation or received intravenous
aminoglycoside antibiotics within 3-months of study entry.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Principal Investigator

Paul Beringer, PharmD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California

Authority:

United States: Institutional Review Board

Study ID:

Kidney Safety - Aminoglycoside

NCT ID:

NCT01543620

Start Date:

February 2012

Completion Date:

September 2013

Related Keywords:

  • Cystic Fibrosis
  • kidney safety
  • biomarkers
  • serum creatinine
  • BUN
  • cystic fibrosis
  • head and neck cancer
  • renal injury
  • drug induced acute kidney injury
  • aminoglycoside
  • cisplatin
  • nephrotoxicity
  • biomarker qualification
  • Cystic Fibrosis
  • Fibrosis

Name

Location

University of Southern CaliforniaLos Angeles, California  90033
University of Minnesota - Cystic Fibrosis CenterMinneapolis, Minnesota  55455